Long-term Treatment With Tenofovir Alafenamide for Chronic Hepatitis B Results in High Rates of Viral Suppression and Favorable Renal and Bone Safety.
Am J Gastroenterol
; 2023 Aug 10.
Article
en En
| MEDLINE
| ID: mdl-37561058
ABSTRACT
OBJECTIVES:
Results from two Phase 3 studies, through 2 years, in chronic hepatitis B infection (CHB) showed tenofovir alafenamide (TAF) had similar efficacy to tenofovir disoproxil fumarate (TDF) with superior renal and bone safety. Here, we report updated results through 5 years.METHODS:
Patients with HBeAg-negative or -positive CHB with or without compensated cirrhosis were randomized (21) to TAF 25 mg or TDF 300 mg once daily in double-blind (DB) fashion for up to 3 years, followed by open-label (OL) TAF up to 8 years. Efficacy (antiviral, biochemical, serologic), resistance (deep sequencing of polymerase/reverse transcriptase and phenotyping), and safety, including renal and bone parameters, were evaluated by pooled analyses.RESULTS:
Of 1298 randomized and treated patients, 866 receiving TAF (DB and OL) and 432 receiving TDF with rollover to OL TAF at year 2 (n = 180; TDFâTAF3y) or year 3 (n = 202; TDFâTAF2y) were included. Fifty (4%) TDF patients who discontinued during DB were excluded. At year 5, 85%, 83%, and 90% achieved HBV DNA < 29 IU/mL (missing = failure) in the TAF, TDFâTAF3y, and TDFâTAF2y groups, respectively; no patient developed TAF or TDF resistance. Median eGFR (by Cockcroft-Gault) declined < 2.5 mL/min, and mean declines of < 1% in hip and spine bone mineral density were seen at year 5 in the TAF group; patients in the TDFâTAF groups had improvements in these parameters at year 5 after switching to OL TAF.CONCLUSIONS:
Long-term TAF treatment resulted in high rates of viral suppression, no resistance, and favorable renal and bone safety.
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Bases de datos:
MEDLINE
Tipo de estudio:
Clinical_trials
Idioma:
En
Revista:
Am J Gastroenterol
Año:
2023
Tipo del documento:
Article